Locomotion Adaptation Deficits in Older Adults With Mild Cognitive Impairment and Alzheimers Disease
Recruiting · NCT06484244 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
5 Sessions of Split-belt Treadmill-based Locomotor Adaptation
What this trial is about
In people with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD), reduced capacity for locomotor adaptation is a fundamental but poorly understood mechanism that can be a sensitive biomarker of cognitive-motor impairments. It is also an important therapeutic target for exercise-based interventions to improve walking function. The overall goal of this study is to understand the effects of MCI and AD on locomotor adaptation and walking function.
Who can take part
Age range
50 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- AD and MCI will be defined through formal diagnosis provided by a board-certified Neurologist. Amnestic MCI will be defined using the AD Neuroimaging Initiative (ADNI) criteria. All MCI participants in ADNI are required to have an amnestic subtype defined as:
- Subjective memory concern or a memory problem noted by their partner
- Abnormal memory function documented by a specified education adjusted cutoff score on the delayed paragraph recall of the Anna Thompson story of the Logical Memory subtest from the Wechsler Memory Scale-Revised
- Mini-Mental State Exam (MMSE) score between 20 and 26 (inclusive). Exceptions may be made for subjects with less than 8 years of education at the discretion of the PI. (iv) Single or multi-domain amnestic MCI (both subtypes are at high risk for progression to AD)
- Clinical Dementia Rating (CDR) = 0.5 (Memory Box score must be at least 0.5)
- General functional performance sufficiently preserved
- Evidence of impaired executive function based on Montreal Cognitive Assessment (MoCA) score 13-17
- Able to walk 10 or more feet without an assistive device
- Completed six grades of education or has a good work history (sufficient to exclude intellectual disabilities)
- Not hospitalized within the last 60 days
Exclusion criteria
- Acute medical illness requiring hospitalization
- Uncontrolled congestive heart failure
- History of stroke
- Inability to perform study procedures
- Medical or physical conditions that would preclude participation or walking (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity)
- On medications that could adversely affect cognition, eg: antipsychotics, opioids, stimulants, chemotherapy, anti-parkinsonian drugs (eg Levodopa), neurologic prescriptions to treat Multiple sclerosis and/or Parkinson's
- Psychotic disorders
- Confounding neurologic conditions (e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness \>30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae)
- Substance Use Disorder, Major Depressive and Generalized Anxiety Disorders within six months of evaluation
Where it is running
1 location listed across 1 US state.
- Emory Rehabilitation Hospital - Atlanta, Georgia, United States